ArticleBalsløv JT, Brun C, Jørgensen F, Jørgensen HE, Larsen M, Larsen S, Lorenzen I, Thomsen AC.
Acta Med Scand. 1978;203(5):339-44.
Sequential statistical testing of the development of the disease in the single patient was used in the assessment of immunosuppressive treatment of renal glomerular diseases. After an initial period of prednisone (P) treatment, this was supplemented first by azathioprine (A) and later in addition by cyclophosphamide (C). The time of transition from one treatment to another was determined by the result of the current statisical testing of the correlation between serum creatinine concentration and proteinuria on the one hand and the time and the varying doses of the drugs on the other. Twenty-nine patients entered the study. Thirteen were withdrawn, eight for technical reasons, three due to side-effects and two on account of renal deterioration and transfer to dialysis treatment. Eight patients were cured, one during P treatment, five during P + A, and two during the combination of P, A and C. Eight patients completed treatment without being cured. In the overall material no statistically significant change in serum creatinine was noted, whereas the proteinuria decreased during P + A and P + A + C. No dose-dependent therapeutic effect of the drugs was demonstrated. In conclusion, this combined treatment with P, A and C did not seem to yield any major therapeutic progress. The technic of sequential statistical testing may be a useful tool in clinical research.